CQV Engineer: GMP Validation for Life Sciences

Verista, Inc.; Indianapolis (IN); On-site; USD 70,000 - 103,000; Full time

Benefits offered by this job

Competitive pay

Job summary

Verista, a life sciences solutions provider, seeks a Service Order CQV Engineer to work on large capital projects involving new or modified equipment and facilities.

The role requires a Bachelor's in Engineering or Science, 1–3 years GMP experience, hands-on experience with automated equipment and validation documents per FDA/ISPE/ISO standards. On-site US position with competitive compensation; salary range $70,491–$102,623.

Qualifications

• Bachelor's degree in Engineering or Science required.
• 1–3 years’ GMP-regulated experience.
• Experience with automated manufacturing equipment (PLCs, HMIs, PC controls).
• Experience authoring and executing validation documents (FAT, IQ, OQ, PQ) and change controls.
• Knowledge of FDA regulations, ISPE guidelines, ISO standards, GDP.

Responsibilities

• Provide CQV expertise on large capital projects involving equipment, facilities and utilities.
• Author and execute commissioning and qualification documentation per quality standards and regulations.
• Review system drawings including P&IDs and I&C drawings with electrical support.
• Collaborate with client quality representatives to close deviations and maintain records.
• Projects vary by customer requirements and defined deliverables.

Skills

GMP experience

Automated manufacturing equipment

Validation document authoring

FDA regulations & ISO standards know‑l

ASTM‑E2500

Education

Bachelor’s degree in Engineering or Science

Job description

Verista, a life sciences solutions provider, seeks a Service Order CQV Engineer to work on large capital projects involving new or modified equipment and facilities.

The role requires a Bachelor's in Engineering or Science, 1–3 years GMP experience, hands-on experience with automated equipment and validation documents per FDA/ISPE/ISO standards. On-site US position with competitive compensation; salary range $70,491–$102,623.